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  4. NDC Product Code: 0074-2625 Mavyret

NDC 0074-2625 Mavyret

Glecaprevir And Pibrentasvir Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0074-2625?
  5. Mavyret Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
0074-2625
Proprietary Name:
Mavyret
Non-Proprietary Name: [1]
Glecaprevir And Pibrentasvir
Substance Name: [2]
Glecaprevir; Pibrentasvir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0074
    Product Label ID:
    7bf99777-0401-9095-8645-16c6e907fcc0
    FDA Application Number: [6]
    NDA209394
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-03-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    Imprint(s):
    NXT
    Score:
    1

    Product Packages

    NDC Code 0074-2625-01

    Package Description: 1 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK

    Price per Unit: $152.56411 per EA

    NDC Code 0074-2625-28

    Package Description: 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK

    Price per Unit: $152.56411 per EA

    NDC Code 0074-2625-56

    Package Description: 2 CARTON in 1 CARTON / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK

    NDC Code 0074-2625-84

    Package Description: 84 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $152.56411 per EA

    Product Details

    What is NDC 0074-2625?

    The NDC code 0074-2625 is assigned by the FDA to the product Mavyret which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Mavyret is glecaprevir and pibrentasvir. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 0074-2625-01 1 dose pack in 1 carton / 3 tablet, film coated in 1 dose pack, 0074-2625-28 4 carton in 1 carton / 7 dose pack in 1 carton / 3 tablet, film coated in 1 dose pack, 0074-2625-56 2 carton in 1 carton / 4 carton in 1 carton / 7 dose pack in 1 carton / 3 tablet, film coated in 1 dose pack, 0074-2625-84 84 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Mavyret?

    This medication is a combination of glecaprevir and pibrentasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Glecaprevir and pibrentasvir work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis) or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

    What are Mavyret Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Mavyret UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Mavyret Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Mavyret?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1940703 - glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet
    • RxCUI: 1940709 - Mavyret 100 MG / 40 MG Oral Tablet
    • RxCUI: 1940709 - glecaprevir 100 MG / pibrentasvir 40 MG Oral Tablet [Mavyret]
    • RxCUI: 1940709 - Mavyret (glecaprevir 100 MG / pibrentasvir 40 MG) Oral Tablet
    • RxCUI: 2557906 - glecaprevir 50 MG / pibrentasvir 20 MG per packet Oral Pellet

    Which are the Pharmacologic Classes for Mavyret?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Glecaprevir and Pibrentasvir


    The combination of glecaprevir and pibrentasvir is used to treat certain types of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults and children 3 years of age and older. It is also used to treat certain types of chronic hepatitis C infection in adults and children 3 years of age and older who have already received another medication to treat their hepatitis C infection. Glecaprevir is in a class of medications called HCV NS3/4A protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Pibrentasvir is in a class of medications called HCV NS5A inhibitors. It works by stopping the virus that causes hepatitis C to spread inside the body.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".